Digitization has made industries innovate and adopt efficient service-delivery techniques. One such innovation is the electronic case report form (eCRF.) Medical researchers are using this technology in clinical trials to collect data. Clinical trials are a crucial aspect of the medical field. They lead to the discovery of new drugs and cures to illnesses, bettering the health of nations. Medical researchers require accurate data to make such breakthroughs. You can only collect accurate and high-quality data by ensuring the system is used to do this efficiently in its operations. In this case, the eCRF.
Therefore, how do you design your eCRF to ensure a quality-driven data collection process? Read on to learn the tips you can adopt, even as a beginner, to develop the best design.
Collect Quantifiable Data
Data collection helps with your analysis, enabling you to conclude your clinical study. You can collect qualitative or quantitative data. Qualitative data often contains opinions regarding a given question, while quantitative data deals with numbers. By default, measuring opinions is challenging, hence the need to collect quantifiable data. How do you do this?
Consider adopting pre-coded answers that’ll give you factual data without the need to make assumptions. For example, seek yes and no; or high, moderate, and low answers, among others. You can easily count the number of yeses and nos, giving you the ability to make valid conclusions.
Refrain from seeking free-text answers where the patient explains their response. It can lead to misinterpretation. However, it’s good to note that you can adopt both systems on one question, where the patient answers yes or no, then proceeds to explain. The free text aspect helps you understand the reason for the choice of answer, further aiding your clinical trial.
Simplicity is key for CRFs in clinical trials. You want your patients to have an easy time with the form and understand the questions as you want them to.
Adopt simplicity by using simple language. It’s best to use a universal language that all patients understand, despite their native language. However, you can decide to stick to a native language if all the patients originate from a similar community and not all of them have an understanding of the universal language. Also, please refrain from using jargon, especially those in the medical field. Not everyone is proficient with medical terms. Adopting a complex language will create room for misinterpretation, leading to wrong data collection.
As part of simplicity, it’d help provide instructions on how to go about the filling-in process. Consider placing the instructions at the beginning of the ECRF and starting each section of your questions. There are situations where you have no choice but to use jargon due to the lack of alternative words. Be sure to explain the word’s meaning to ensure the patients understand it before answering.
Incorporate Edit Checks
When filling out electronic case report forms, patients might make errors. These errors need correction for you to utilize the said data. The correction procedure is referred to as data cleansing. Data cleansing often increases the clinical trial time, which is undesirable. The more time spent, the more you’ll invest your resources, increasing expenditure.
Therefore, consider adding edit checks to the forms. Edit checks will notify the patients of any errors they’ve made when filling out the form. Also, it won’t submit the form until the patient adjusts their answers accordingly. However, you can only do this by adding the correct settings to your form. You can dictate that a given section of the form should have a given type of answer. The system will highlight any deviation.
It’s good that even as the edit checks fail to submit error-filled forms, ensure the system directs the patient to where the error is. The system should also guide them appropriately to prevent frustrating the patients. Imagine a situation where you’re informed you’ve made an error and can’t trace it. The frustration of not finding the error or getting appropriate guidance can make you abandon the process altogether.
Include Mandatory Sections
A clinical trial relies on data to be a success. You’ll get this data through an eCRF. Different types of data have varying significance to your trial. Some are the cornerstone; others are minor. Some patients might leave some sections blank accidentally or on purpose when collecting data. The areas left blank might be what your entire clinical trial relies on; what will happen with the missing data? In most cases, you’ll have no option but to repeat the data collection process, lengthening the process. As an eCRF designer, you can eliminate these negative possibilities by introducing mandatory fields in your form.
The mandatory fields will inform the patient about the data they must fill in to submit the form. Include the mandatory fields only on the essential data you need. You want to give your patients the option of answering the less important data. You won’t come off as controlling, an aspect that might rub off wrongly with some patients, causing them to abandon the process.
There’s no case where you’ll receive filled forms without your needed data with mandatory fields.
User-friendliness is essential; it’ll determine if your patients will proceed to fill in the forms. No one wants to work with a complex system. In most cases, an eCRF requires a platform for your patients to access the case report forms. Therefore, it’s essential that you also make the platform user-friendly. How?
Consider incorporating a menu. A menu will give patients direct access to the information they need from your platform. Ensure the menu provides access to all sections in your platform. It’d also help to have the necessary call-to-action buttons, such as the telephone number and email address. Some patients might get stuck and need assistance filling out the eCRFs. With call-to-actions, they can easily contact you for help.
Now, you’re dealing with patients of different characters; some like being independent, while others do not mind assistance. It’s best to meet both their needs. Consider adding a Frequently Asked Questions (FAQ) section on the platform. Those needing assistance can go through this and find solutions to problems they face as they fill the eCRFs independently. Adding blogs could prove to be beneficial to the patients. The blogs could contain data on clinical trials and everything involved; you want your patients to understand and know the importance of what they’re doing. This way, you’re likely to have a 100% transition of all the patients; none will leave the process midway.
Organize The Form
Organizing your eCRF impacts the patients’ first impression of the data collection. A disorganized form can put off some patients, with others abandoning the process midway. How do you organize your form?
Start by utilizing the correct font size for the wording. The font shouldn’t be too big or too small. A huge font will portray a negative tone towards the patient (like shouting), while tiny fonts will make it difficult for some patients to point out the words. Therefore, you must find a balance between the two fonts to avoid creating negative emotions for your patients. A patient might decide to give the wrong data because they’re angry.
The other trick is to minimize the form’s pages to the bare minimum. Do this by collecting only relevant data; it’ll reduce the amount of data you’ll collect. Many pages may overwhelm the patients before they start filling in your eCRF. Also, consider sectioning your questions to make the form appear smaller than it is.
Designing an electronic case report form (eCRF) isn’t challenging, whether you’re a beginner or a guru. With the proper guidance, you can create the best design for your forms to aid in an accurate and efficient data-collection procedure. This article has discussed tips you can adopt during design. Consider adopting them, and you’ll succeed in your clinical trial.
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